Issue link: https://www.e-digitaleditions.com/i/1056686
Recent news items on research and development, and progress in the treatment of respiratory diseases, such as asthma and COPD. Inhalation December 2018 9 version of Breo ® Ellipta (flutica- sone furoate and vilanterol trife- natate) will be prioritized for the first wave of development. Vec- tura will be responsible for and fund initial device and formula- tion development. Hikma will be responsible for clinical develop- ment, regulatory submission and commercialization activities. Janssen files with EMA for nasal spray to treat major depressive disorder BEERSE, BELGIUM—Pharma Times Online reported that Janssen Pharmaceutica has submitted a marketing application to the Euro- pean Medicines Agency (EMA) seeking approval of the investiga- tional nasal spray esketamine for the treatment of major depressive disorder (MDD). Esketamine, the first new treatment option in 30 years, has been developed for treat- ment-resistant depression (TRD) in adults with MDD who have not responded to at least two different treatments with antidepressants in the current moderate-to-severe depressive episode. It has a novel m e c h a n i s m o f a c t i o n a n d i s believed to help restore synaptic c o n n e c t i o n s i n b r a i n c e l l s o f patients with TRD. Earlier in 2018, Janssen presented data showing that continuing treatment with esketamine nasal spray plus an oral antidepressant in patients beyond 16 weeks "showed clini- cally meaningful and statistically significant superiority" to treat- ment with an oral antidepressant plus placebo nasal spray, in delay- ing time to relapse of symptoms of depression. In addition, patients in stable remission treated with esket- amine nasal spray plus an oral anti- depressant reduced the risk of relapse by 51 percent compared to patients receiving an oral antide- pressant plus placebo nasal spray. EU orphan drug status recommended for Santhera's potential CF inhalation therapy P R A T T E L N , S W I T Z E R - L AN D—C ystic F ibrosis N ews Today reported that POL6014, an investigative inhalation therapy for cystic fibrosis from Santhera Pharmaceuticals, has been favored f o r o r p h a n d r u g d e s i g n a t i o n within the European Union. e recommendation was made by the Committee for Orphan Medicinal Products (COMP), a branch of the European Medicines Agency (EMA). e European Commis- sion is considering the positive opinion, with a decision expected in November (as this issue of Inha- lation went to publication). Gen- erally, committee recommenda- tions are supported. The orphan drug designation would give San- thera regulatory and financial incentives to develop POL6014 for treatment of CF. POL6014 is a highly potent, selective inhibitor of human neutrophil elastase (hNE), an enzyme released by neutrophils and macrophages. POL6014 reached high concen- trations in the lung when inhaled using an optimized eFlow ® nebu- l i z e r ( P A R I P h a r m a G m b H ) . During Phase 1 studies in healthy v o l u n t e e r s a n d C F p a t i e n t s , POL6014 was well tolerated and inhibited hNE activity. Santhera is also pursuing POL6014 to treat oth er p ulm on ary con d ition s, in clud in g n on -cystic fibrosis bronchiectasis (NCFB), alpha-1 antitrypsin deficiency and primary ciliary dyskinesia. AztraZeneca sells three inhaled medications to Covis CAMBRIDGE, UNITED KING- DOM—According to Pharma Times Online, AstraZeneca has transferred rights to three of its non- core assets to Covis Pharma. The agreement includes the inhaled anti-inflammatory Alvesco ® (cicle- sonide) for persistent asthma and Omnaris ® and Zetonna™ (cicle- sonide) nasal sprays for treatment of nasal symptoms associated with rhi- nitis. Covis currently sells Alvesco, Omnaris and Zetonna in the United States. Pharma Times Online quoted Mark Mallon, AstraZeneca Executive Vice President, Global Product and Portfolio Strategy, who said, "One of our strategic objectives is to divest parts of our portfolio, allowing us to allocate resources to develop innovative new medicines to address unmet patient needs. Covis Pharma has strong capabili- ties in marketing medicines around the world, and our agreement with them means patients will continue to benefit from Alvesco, Omnaris and Zetonna." RespiRatoRy medicine news Asthma during pregnancy tied to postpartum depression risk MONTREAL, QUEBEC, CAN- A D A — R e u t e r s r e p o r t e d t h a t women who have asthma during pregnancies are more likely to experience postpartum depression following delivery, according to a study from the Universite de Mon- treal, published in in e Journal of Allergy and Clinical Immunology: In Practice. "We knew asthma in general (outside of pregnancy) is associated with an increased risk of depression, so we suspected that asthma during pregnancy could increase the risk of postpartum depression," said researcher and lead author Lucie Blais. She and her colleagues compared health histories of more than 35,000 pregnant women with asthma and almost 200,000 women without asthma who delivered babies in Quebec between 1998 and 2009. After analyzing a variety of factors, they determined women with asthma were 58 percent more likely than those without asthma to experience postpartum depres- sion. e causes are not clear but may be due to increased feelings of anxiety or stress, or to inflamma- tion. The authors caution that physicians should watch for signs of depression in their pregnant patients with asthma so treatment and coping strategies can start e a r l y . I n a n e m a i l t o R e u t e r s Health, Blais advised that "women continued on page 29